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Minos Medical Inc, a pioneer in the emerging field of natural orifice surgery (NOS) and natural orifice transluminal endoscopic surgery (NOTES) announced today it had gained CE mark for their range of Appendoectomy™ products designed to enable a colonic, endoluminal removal of the appendix.

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Appendectomy is one of the most frequent surgical procedures performed. In the western world alone it is estimated that over 800,000 procedures are performed annually, most as emergency admissions. The most common way to remove the appendix today is a small incision in the lower right quadrant -- this incision is painful and invades the abdomen, carrying certain risks. The next most common way is to use laparoscopy, or keyhole surgery -- again invading the abdomen, and requiring highly skilled laparoscopic training.

The appendix is a small "worm like" structure that is connected by a small orifice (hole) to the caecum (a part of the colon). Because of this orifice, an endoscopist can pass devices into the appendix without ever going into the abdominal space. This opens up the possibility to reach into the appendix, grab it by its tip and then pull it back into the colon, bringing with it the artery that supplies the blood to the appendix. The appendix can then be snared and closed before being removed like a polyp.

"Not all appendices will be suitable for this procedure," said Prof Christoph Gasche of the Medical University of Vienna, Austria, the lead investigator in this pioneering procedure. "But ones that have limited inflammation, and only a few adhesions may be good candidates for the inversion technique."

The Appendoectomy™ procedure is performed by using a standard colonoscope. Mounted on the scope is the revolutionary Megachannel™, Minos Medical's colonic access device. The scope and Megachannel™ are guided to the caecum where the orifice of the appendix can be identified.

A guide wire is used to enter the appendix via the orifice, and this allows a dilating balloon to enter the appendix and stretch open the orifice, allowing easier inversion. The next step requires the proprietary manipulator catheter, a small soft catheter that enters the appendix and cleans it out by using irrigation.

"The cleaning of the appendix from the inside offers a major potential advantage," said Prof Gasche. "Infectious materials can be removed prior to the surgical intervention. We can also deliver contrast media to get a better image of the appendix prior to attempting the removal."

Once it has been assessed that the appendix is suitable for removal, a proprietary inversion catheter is introduced -- the AID -- Appendoectomy™ Inverter Device. This crucial instrument utilises a unique tip gripping system plus vacuum assist, allowing the crucial base inversion of the appendix. The Megachannel™ is utilized for the inversion by acting as a counter force on the caecum to allow base inversion of the appendix.

Once inverted a suture loop is deployed and the appendix, plus artery, are ligated. The appendix is then simply removed using a polyp snare. The specimen is retrieved whole through the 20mm working channel of the Megachannel™ and the scope immediately returned along the access device to inspect the appendix stump for good closure.

"We are in the early stages with the procedure," said Brad Sharp, CEO of Minos Medical. "But we've done a lot of lab work to refine these first generation products. We are doing a series of further laboratory, and clinical trials with the devices before we release a commercial version. This certainly demonstrates our innovation in the emerging field of NOS and NOTES. Crucially it shows how we are building a family of technologies based upon our Megachannel™ device. We will be unveiling an entire series of products for both endoluminal and transluminal procedures in the near future."

Major benefits of the Appendoectomy™ procedure are yet to be proven out in clinical trials, but potential benefits are the elimination of any skin incisions, no invasion of the abdominal cavity, no need for insufflation, and the possibility to do the procedure in the outpatient department under sedation.

"We have already come a long way in developing this procedure," said Prof Gasche, "With the first set of functional devices in hand we will start with simple cases in the operating room environment. Initial cases will be under laparoscopic control and part of a clinical trial. Once we prove safety and efficacy in a larger cohort, it may be possible to move the procedure to the endoscopy suite. Our primary concerns in developing the Appendoectomy™ procedure have been and will continue to be patient's safety and benefit."

About Minos Medical Inc
Minos Medical is a privately owned medical device company based in Irvine, California. It holds a major intellectual property estate directed purely at natural orifice surgery (NOS) and natural orifice transluminal endoscopic surgery (NOTES). The company is collaborating with some of the major world opinion leaders and institutions involved in this emerging field.